Chinese acute ischemic stroke treatment outcome registry (CASTOR): protocol for a prospective registry study on patterns of real-world treatment of acute ischemic stroke in China

Weiping Sun, Qianhua Ou, Zhijun Zhang, Jiazhi Qu, Yining Huang, Weiping Sun, Qianhua Ou, Zhijun Zhang, Jiazhi Qu, Yining Huang

Abstract

Rationale: Stroke presents a serious health problem in China. Despite progresses made in recent years, there is still a lack of effective treatments for acute ischemic stroke (AIS) in clinical practices.

Aims: The Chinese Acute Ischemic Stroke Treatment Outcome Registry (CASTOR) is designed to evaluate the patterns and cost-effectiveness of current treatments for AIS in real-world settings in China.

Design: CASTOR is a prospective, multi-center study registered with ClinicalTrials.gov (NCT02470624) with a target sample size of 10,000 patients who are experiencing AIS. The patients are treated for AIS following the Chinese stroke guideline and local practice. Real-world data on treatment regimens, outcomes and costs are collected at baseline (Visit 1) and during subsequent visits (Visit 2 to Visit 5) after medication treatments.

Outcome: The primary objective of the present study is to analyze the current treatment status of AIS in real world settings. The secondary objectives include: 1) to compare the effectiveness of common treatment regimens, 2) to analyze the cost-effectiveness of different treatment regimens for AIS, 3) to analyze the incidence of adverse events and complications in enrolled patients with AIS, 4) to analyze the effect of Trial of Org 10,172 in Acute Stroke Treatment (TOAST) classification on the specific therapies during acute phase treatment period.

Discussion: In face of changing treatment patterns and increasing demand from medical insurers for cost-effectiveness data in China, a large-scale registry study examining the real-world patterns of AIS in hospitals is needed. The CASTOR study will help to find favorable cost-utility treatment regimens for AIS and improve the overall treatment outcome of Chinese patients with AIS.

Keywords: Acute ischemic stroke; Cost-effectiveness; Cost-utility; Outcome; Protocols; Registry study; Therapy.

Conflict of interest statement

Authors’ information

Weiping Sun (M.D.) and Yining Huang (M.D.), Major Research Direction: Neurology. Department of Neurology, Peking University First Hospital.

Qianhua Ou, Zhijun Zhang and Jiazhi Qu, Department of medical affairs, Techpool Bio-Pharma Co., LTD.

Ethics approval and consent to participate

This study will be carried out according to the Declaration of Helsinki, the NHMRC National Statement on Ethical Conduct in Research Involving Humans. The study has been approved by the Ethics Committee of all participating hospitals. The informed consents will be obtained from the eligible participants before participation in the study.

Consent for publication

The authors declare that they consent for publication.

Competing interests

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study schedule of assessments. GCS, Glasgow coma Scale; NIHSS, National Institutes of Health Stroke Scale; mRS, Modified Rankin Scale; EQ-5D, EuroQol-5 Dimensions; MMSE, Mini-mental state examination; TOAST, Trial of Org 10,172 in Acute Stroke Treatment; ECG, Electrocardiograph. a. Visit 2 could be skipped if the patient is discharged at that time; b. optional items; c. It includes stroke, hypertension, diabetes, dyslipidemia, coronary heart disease, atrial fibrillation, carotid plaques, and tumors; d. MMSE is available for outpatient visits of visit 4; e. It includes body temperature, pulse, respiration and blood pressure, and body temperature should be collected at admission and 24 h after admission at visit 1; f. It includes examinations of blood routine test, blood glucose, blood lipids, liver and renal functions, myocardial enzymes, serum electrolytes, and coagulation function; g. It refers to the specific treatments for AIS, and the non-specific treatments will be recorded in the item “combined medications”; h. It is recorded from the time of obtaining the signed informed consent form to 30 days after the last administration; i. It refers to the direct costs, including the direct medical costs and the direct non-medical costs

References

    1. Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S. Heart disease and stroke statistics-2014 update. Circulation. 2014;129(3).
    1. Liu L, Wang D, Wong KS, Wang Y. Stroke and stroke care in China: huge burden, significant workload, and a national priority. Stroke. 2011;42(12):3651–3654. doi: 10.1161/STROKEAHA.111.635755.
    1. Yang G, Wang Y, Zeng Y, Gao GF, Liang X, Zhou M, Wan X, Yu S, Jiang Y, Naghavi M, et al. Rapid health transition in China, 1990-2010: findings from the global burden of disease study 2010. Lancet. 2013;381(9882):1987–2015. doi: 10.1016/S0140-6736(13)61097-1.
    1. Wang YJ, Zhang SM, Zhang L, Wang CX, Dong Q, Gao S, Huang RX, Huang YN, Lv CZ, Liu M, et al. Chinese guidelines for the secondary prevention of ischemic stroke and transient ischemic attack 2010. CNS neuroscience & therapeutics. 2012;18(2):93–101. doi: 10.1111/j.1755-5949.2011.00290.x.
    1. Kolominskyrabas PL, Weber M, Gefeller O, Neundoerfer B, Heuschmann PU: Epidemiology of ischemic stroke subtypes according to TOAST criteria: incidence, recurrence, and long-term survival in ischemic stroke subtypes: a population-based study. 2001;32(12):2735–2740.
    1. Liu M, Wu B, Wang WZ, Lee LM, Zhang SH, Kong LZ. Stroke in China: epidemiology, prevention, and management strategies. The Lancet Neurology. 2007;6(5):456–464. doi: 10.1016/S1474-4422(07)70004-2.
    1. Chen Z. The third national survey on the cause of death. Ministry of Health, People's Republic of China: Peking Union Medical University Press; 2008.
    1. Wang C, Li J, Zhao X, Wang Y, Wu D, Wang Y. Stroke care development in mainland China: past, present and future. International journal of stroke: official journal of the International Stroke Society. 2008;3(4):288–289. doi: 10.1111/j.1747-4949.2008.00218.x.
    1. Chinese Guidelines Revision Committee of Prevention and Treatment for Hypertension Chinese guidelines of prevention and treatment for hypertension (2005 revision edition) Chin J Hypertens. 2005;13:5–41.
    1. Hacke W, Kaste M, Bluhmki E, Brozman M, Davalos A, Guidetti D, Larrue V, Lees KR, Medeghri Z, Machnig T, et al. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med. 2008;359(13):1317–1329. doi: 10.1056/NEJMoa0804656.
    1. Wahlgren N, Ahmed N, Dávalos A, Ford GA, Grond M, Hacke W, Hennerici MG, Kaste M, Kuelkens S, Larrue V. Thrombolysis with alteplase for acute ischaemic stroke in the safe implementation of thrombolysis in stroke-monitoring study (SITS-MOST): an observational study. Lancet. 2007;369(9558):275–282. doi: 10.1016/S0140-6736(07)60149-4.
    1. Xydas T, Georgantopoulos C, Bethanis D, Sarris M. Thrombolysis for Acute Ischemic Stroke: a New Paradigm. Hosp Chron. 2012;7(1 Sup):77–80.
    1. 95s' Project: Intravenous thrombolysis with urokinase for acute cerebral infarctions. Chin J Neurol. 2002;35(4):210–213.
    1. Heuschmann PU, Kolominskyrabas PL, Roether J, Misselwitz B, Lowitzsch K, Heidrich J, Hermanek P, Leffmann C, Sitzer M, Biegler M. Predictors of in-hospital mortality in patients with acute ischemic stroke treated with thrombolytic therapy. JAMA. 2004;14(1):1831. doi: 10.1001/jama.292.15.1831.
    1. Minnerup J, Wersching H, Teuber A, Wellmann J, Eyding J, Weber R, Reimann G, Weber W, Krause LU, Kurth T. Outcome after Thrombectomy and intravenous thrombolysis in patients with acute ischemic stroke: a prospective observational study. Stroke. 2016;47(6):1584. doi: 10.1161/STROKEAHA.116.012619.
    1. Saver JL, Goyal M, Bonafe A, Diener HC, Levy EI, Pereira VM, Albers GW, Cognard C, Cohen DJ, Hacke W. Stent-retriever Thrombectomy after intravenous t-PA vs. t-PA alone in stroke. N Engl J Med. 2015;372(24):2285–2295. doi: 10.1056/NEJMoa1415061.
    1. Berkhemer OA, Fransen PS, Beumer D, La VDB, Lingsma HF, Yoo AJ, Schonewille WJ, Vos JA, Nederkoorn PJ, Wermer MJ. A randomized trial of intraarterial treatment for acute ischemic stroke. N Engl J Med. 2015;372(1):11. doi: 10.1056/NEJMoa1411587.
    1. Campbell BC, Mitchell PJ, Kleinig TJ, Dewey HM, Churilov L, Yassi N, Yan B, Dowling RJ, Parsons MW, Oxley TJ. Endovascular therapy for ischemic stroke with perfusion-imaging selection. N Engl J Med. 2015;372(11):1009–1018. doi: 10.1056/NEJMoa1414792.
    1. Goyal M, Demchuk AM, Menon BK, Eesa M, Rempel JL, Thornton J, Roy D, Jovin TG, Willinsky RA, Sapkota BL. Randomized assessment of rapid endovascular treatment of ischemic stroke. N Engl J Med. 2015;372(11):1019. doi: 10.1056/NEJMoa1414905.
    1. Jovin TG, Chamorro A, Cobo E, de Miquel MA, Molina CA, Rovira A, San RL, Serena J, Abilleira S, Ribó M. Thrombectomy within 8 hours after symptom onset in ischemic stroke. N Engl J Med. 2015;372(24):2296–2306. doi: 10.1056/NEJMoa1503780.
    1. Wang Y, Cui L, Ji X, Dong Q, Zeng J, Wang Y, Zhou Y, Zhao X, Wang C, Liu L, et al. The China National Stroke Registry for patients with acute cerebrovascular events: design, rationale, and baseline patient characteristics. International journal of stroke : official journal of the International Stroke Society. 2011;6(4):355–361. doi: 10.1111/j.1747-4949.2011.00584.x.
    1. Wang X, Wang Y, Wang C, Zhao X, Xian Y, Wang D, Liu L, Luo Y, Liu G, Wang Y. Association between estimated glomerular filtration rate and clinical outcomes in patients with acute ischaemic stroke: results from China national stroke registry. Age Ageing. 2014;43(6):839–845. doi: 10.1093/ageing/afu090.
    1. Meng X, Chen Y, Jing J, Zhao X, Wang C, Liu L, Wang A, Pan Y, Li C, Wang Y. Association between polyvascular atherosclerosis and estimated glomerular filtration rate in patients with ischaemic stroke: data analysis of the patients in the Chinese national stroke registry. Neurol Res. 2015;37(5):415–420. doi: 10.1179/1743132815Y.0000000029.
    1. Li Z, Zhao X, Wang Y, Wang C, Liu L, Shao X, Wang W, Pan Y, Wang C, Ji R, et al. Association between seizures and outcomes among intracerebral hemorrhage patients: the China national stroke registry. Journal of stroke and cerebrovascular diseases: the official journal of National Stroke Association. 2015;24(2):455–464. doi: 10.1016/j.jstrokecerebrovasdis.2014.09.021.
    1. Luo Y, Wang X, Wang Y, Wang C, Wang H, Wang D, Liu L, Jia Q, Liu G, Zhao X, et al. Association of glomerular filtration rate with outcomes of acute stroke in type 2 diabetic patients: results from the China national stroke registry. Diabetes Care. 2014;37(1):173–179. doi: 10.2337/dc13-1931.
    1. Jia Q, Zhao X, Wang C, Wang Y, Yan Y, Li H, Zhong L, Liu L, Zheng H, Zhou Y, et al. Diabetes and poor outcomes within 6 months after acute ischemic stroke: the China National Stroke Registry. Stroke. 2011;42(10):2758–2762. doi: 10.1161/STROKEAHA.111.621649.
    1. Chinese Society of Neurology Cerebrovascular disease Group of the Chinese Society of neurology: Chinese guidelines of diagnosis and treatment for acute ischemic stroke (2014) Chin J Neurol. 2015;48(4):246–257.
    1. Phillips C, Thompson G. What is QALY? (second edition) Health Econ. 2009;1:400–405.
    1. Shi R, Zhang R, Yang F, Lin M, Li M, Liu L, Yin Q, Lin H, Xiong Y, Liu W, et al. Tissue Kallikrein prevents restenosis after stenting of severe atherosclerotic stenosis of the middle cerebral artery: a randomized controlled trial. Medicine. 2016;95(6) doi: 10.1097/MD.0000000000002809.

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe